Fredrik Borgström

European guidance for the diagnosis and management of osteoporosis in postmenopausal women

Summary Guidance is provided in a European setting on the assessment and treatment of postmenopausal women at risk of fractures due to osteoporosis. Introduction The International Osteoporosis Foundation and European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis published guidance for the diagnosis and management of osteoporosis in 2008. This manuscript updates these in a European setting. Methods Systematic literature reviews. Results The following areas are reviewed: the role of bone mineral density measurement for the diagnosis of osteoporosis and assessment of fracture risk, general and pharmacological management of osteoporosis, monitoring of treatment, assessment of fracture risk, case finding strategies, investigation of patients and health economics of treatment. Conclusions A platform is provided on which specific guidelines can be developed for national use.

Impact of Osteoporosis Treatment Adherence on Fracture Rates in North America and Europe

Fragility fractures associated with osteoporosis constitute a significant public health concern. Clinical trials have shown that a variety of agents--bisphosphonates, raloxifene, calcitonin, hormone replacement therapy, teriparatide, and strontium ranelate--can reduce the risk of osteoporosis-related fragility fractures. However, low levels of compliance and persistence in the real-life setting mean that efficacy benefits observed in clinical trials with these agents may not translate into equivalent effectiveness in daily practice. The aim of this review is to provide a comprehensive evaluation of compliance and persistence data from retrospective/observational studies, with particular reference to studies that consider the effects on fracture rates. PubMed of the National Center for Biotechnology Information (NCBI) and Web of Science databases were searched for publications detailing observational or retrospective analyses of adherence, compliance, and persistence with osteoporosis therapies. In addition, authors provided relevant studies that were not retrieved using the search criteria. In total, 17 unique publications were identified. Analysis of the publications indicated that low compliance and persistence rates for osteoporosis therapies in the real-life setting result in increased rates of fragility fractures. The results emphasize the importance of good treatment compliance and persistence with osteoporosis therapies in order to achieve a significant therapeutic benefit and thereby reduce the burden that osteoporosis and associated fractures place on individuals and healthcare systems.

Cost-effectiveness of the treatment and prevention of osteoporosis : a review of the literature and a reference model

ObjectiveThe purpose of the paper is to update and review the latest developments related to modelling and economic evaluation of osteoporosis in the period 2002–2005 and further to present a reference model for the assessment of the cost-effectiveness of the prevention and treatment of osteoporosis.DiscussionThe reference model is intended to be used for fracture specific interventions affecting the risk of fracture. An interface version and an extensive description of the model is available on the internet (http://www.healtheconomics.se) and also accessible via the International Osteoporosis Foundation (http://www.osteofound.org). The purpose of the reference model is to improve the quality and comparability of cost-effectiveness analysis in the osteoporosis field and to serve as a tool for validation of present and future cost-effectiveness models. The reference model allows the cost-effectiveness analysis to be carried out from a societal perspective including intervention, morbidity and mortality costs. The model has been extensively tested and calibrated, and meets the properties of good decision analytic modelling. The model is a state transition Markov cohort model, which is characterised by a 50-year time horizon divided into one year cycle lengths. The following health states are included: “healthy”, “hip fracture”, “spine fracture”, “wrist fracture”, “other fracture”, and “dead”.ConclusionThe model is flexible and allows for the estimation of the cost-effectiveness over different ranges for a selected number of variables (e.g., age, fracture risk, cost of intervention).

A Randomized, Controlled Trial of Fusion Surgery for Lumbar Spinal Stenosis

BACKGROUND The efficacy of fusion surgery in addition to decompression surgery in patients who have lumbar spinal stenosis, with or without degenerative spondylolisthesis, has not been substantiated in controlled trials. METHODS We randomly assigned 247 patients between 50 and 80 years of age who had lumbar spinal stenosis at one or two adjacent vertebral levels to undergo either decompression surgery plus fusion surgery (fusion group) or decompression surgery alone (decompression-alone group). Randomization was stratified according to the presence of preoperative degenerative spondylolisthesis (in 135 patients) or its absence. Outcomes were assessed with the use of patient-reported outcome measures, a 6-minute walk test, and a health economic evaluation. The primary outcome was the score on the Oswestry Disability Index (ODI; which ranges from 0 to 100, with higher scores indicating more severe disability) 2 years after surgery. The primary analysis, which was a per-protocol analysis, did not include the 14 patients who did not receive the assigned treatment and the 5 who were lost to follow-up. RESULTS There was no significant difference between the groups in the mean score on the ODI at 2 years (27 in the fusion group and 24 in the decompression-alone group, P=0.24) or in the results of the 6-minute walk test (397 m in the fusion group and 405 m in the decompression-alone group, P=0.72). Results were similar between patients with and those without spondylolisthesis. Among the patients who had 5 years of follow-up and were eligible for inclusion in the 5-year analysis, there were no significant differences between the groups in clinical outcomes at 5 years. The mean length of hospitalization was 7.4 days in the fusion group and 4.1 days in the decompression-alone group (P<0.001). Operating time was longer, the amount of bleeding was greater, and surgical costs were higher in the fusion group than in the decompression-alone group. During a mean follow-up of 6.5 years, additional lumbar spine surgery was performed in 22% of the patients in the fusion group and in 21% of those in the decompression-alone group. CONCLUSIONS Among patients with lumbar spinal stenosis, with or without degenerative spondylolisthesis, decompression surgery plus fusion surgery did not result in better clinical outcomes at 2 years and 5 years than did decompression surgery alone. (Funded by an Uppsala institutional Avtal om Läkarutbildning och Forskning [Agreement concerning Cooperation on Medical Education and Research] and others; Swedish Spinal Stenosis Study ClinicalTrials.gov number, NCT01994512.).

Cost-effectiveness of alendronate in the treatment of postmenopausal women in 9 European countries - an economic evaluation based on the fracture intervention trial

SummaryTreatment with alendronate (Fosamax®) has been shown to significantly reduce the risk of fragility fractures. Cost-effectiveness of treatment was assessed in nine European countries in a Markov model and was generally found to be cost effective in women with a previous spine fracture.IntroductionTreatment with alendronate (Fosamax®) reduces the risk of osteoporotic fractures at the spine, hip and wrist in women with and without prevalent vertebral fracture. Cost-effectiveness estimates in one country may not be applicable elsewhere due to differences in fracture risks, costs and drug prices. The aim of this study was to assess the cost-effectiveness of treating postmenopausal women with alendronate in nine European countries, comprising Belgium, Denmark, France, Germany, Italy, Norway, Spain, Sweden, and the UK.MethodsA Markov model was populated with data for the nine European populations. Effect of treatment was taken from the Fracture Intervention Trial, which recruited women with low BMD alone or with a prior vertebral fracture.ResultsThe cost per QALY gained of treating postmenopausal women with prior vertebral fractures ranged in the base case from “cost saving” in the Scandinavian countries to €15,000 in Italy. Corresponding estimates for women without prior vertebral fractures ranged from “cost saving” to €40,000.ConclusionsIn relation to thresholds generally used, the analysis suggests that alendronate is very cost effective in the treatment of women with previous vertebral fracture, and in women without previous vertebral fracture, cost-effectiveness depends on the country setting, discount rates, and chosen monetary thresholds.

Long-term cost and effect on quality of life of osteoporosis-related fractures in Sweden

Background and purpose Few economic or quality-of-life studies have investigated the long-term consequences of fragility fractures. This prospective observational data collection study assessed the cost and quality of life related to hip, vertebral, and wrist fracture 13–18 months after the fracture, based on 684 patients surviving 18 months after fracture. Patients and methods Data regarding resource use and quality of life related to fractures was collected using questionnaires at 7 research centers in Sweden. Information was collected using patient records, register sources, and by asking the patient. Quality of life was estimated using the EQ-5D questionnaire. Direct and indirect costs were estimated from a societal standpoint. Results The mean fracture-related cost 13–18 months after a hip, vertebral, or wrist fracture were estimated to be €2,422, €3,628, and €316, respectively. Between 12 and 18 months after hip, vertebral, and wrist fracture, utility increased by 0.03, 0.05, and 0.02, respectively. Compared to prefracture levels, the mean loss in quality of life between 13 and 18 months after fracture was estimated to be 0.05, 0.11, and 0.005 for hip, vertebral, and wrist fracture. Interpretation The sample of vertebral fracture patients was fairly small and included a high proportion of fractures leading to hospitalization, but the results indicate higher long-term costs and greater loss in quality of life related to vertebral fracture than previously believed.

Latitude, socioeconomic prosperity, mobile phones and hip fracture risk.

IntroductionEpidemiological observations suggest that sunlight exposure is an important determinant of hip fracture risk. The aim of this ecological study was to examine the relationship between latitude and hip fracture probability.MethodsHip fracture incidence and mortality were obtained from literature searches and 10-year hip fracture probability computed from fracture and death hazards.ResultsThere was a significant association between latitude and 10-year hip fracture probability. For each 10° change in latitude from the equator (e.g., from Paris to Stockholm), fracture probability increased by 0.3% in men, by 0.8% in women and by 0.6% in men and women combined. There was also a significant association between economic prosperity and hip fracture risk as judged by gross domestic product (GDP)/capita or the use of mobile phones/capita. A US

Cost-effectiveness of raloxifene in the UK: an economic evaluation based on the MORE study.

10,000 higher GDP/capita was associated with a 1.3% increase in hip fracture probability. The association between latitude and hip fracture probability persisted after adjusting for indices of economic prosperity.ConclusionsThese findings provide support for an important role of sunlight exposure in the global variation of hip fracture risk. In addition, there is a need to identify the factors related to socioeconomic prosperity that may provide mechanisms for the variation in hip fracture probability worldwide.

SCOPE: a scorecard for osteoporosis in Europe

Raloxifene treatment has been shown to reduce the risk of vertebral fractures and breast cancer in postmenopausal women. The long-term economic implications of treatment with raloxifene have not yet been investigated. The aim of this study was to assess the cost-effectiveness of treating postmenopausal women in the UK with raloxifene. A previously developed computer simulation model was used to estimate the cost-effectiveness of osteoporotic treatments with extra skeletal benefits. The model was populated with epidemiological data and cost data relevant for a UK female population. Data on the effect of treatment were taken from the Multiple Outcomes of Raloxifene (MORE) study, which recruited women with low bone mineral density or with a prior vertebral fracture. Cost-effectiveness was estimated using Quality Adjusted Life Years (QALYs) and life years gained as primary outcome measures. The cost per QALY gained of treating postmenopausal women without prior vertebral fractures was £18,000, £23,000, £18,000 and £21,000 at 50, 60, 70 and 80 years of age. Corresponding estimates for women with prior vertebral fractures were £10,000, £24,000, £18,000 and £20,000. In relation to threshold values that are recommended in the UK, the analysis suggests that raloxifene is cost-effective in the treatment of postmenopausal women at an increased risk of vertebral fractures.

The cost-effectiveness of risedronate in the treatment of osteoporosis: an international perspective

SummaryThe scorecard summarises key indicators of the burden of osteoporosis and its management in each of the member states of the European Union. The resulting scorecard elements were then assembled on a single sheet to provide a unique overview of osteoporosis in Europe.IntroductionThe scorecard for osteoporosis in Europe (SCOPE) is an independent project that seeks to raise awareness of osteoporosis care in Europe. The aim of this project was to develop a scorecard and background documents to draw attention to gaps and inequalities in the provision of primary and secondary prevention of fractures due to osteoporosis.MethodsThe SCOPE panel reviewed the information available on osteoporosis and the resulting fractures for each of the 27 countries of the European Union (EU27). The information researched covered four domains: background information (e.g. the burden of osteoporosis and fractures), policy framework, service provision and service uptake e.g. the proportion of men and women at high risk that do not receive treatment (the treatment gap).ResultsThere was a marked difference in fracture risk among the EU27. Of concern was the marked heterogeneity in the policy framework, service provision and service uptake for osteoporotic fracture that bore little relation to the fracture burden. For example, despite the wide availability of treatments to prevent fractures, in the majority of the EU27, only a minority of patients at high risk receive treatment for osteoporosis even after their first fracture. The elements of each domain in each country were scored and coded using a traffic light system (red, orange, green) and used to synthesise a scorecard. The resulting scorecard elements were then assembled on a single sheet to provide a unique overview of osteoporosis in Europe.ConclusionsThe scorecard will enable healthcare professionals and policy makers to assess their country’s general approach to the disease and provide indicators to inform future provision of healthcare.